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Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial

Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial
Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial
Background
Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.

Methods
In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2?8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.

Findings
Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40 children in the oral steroid group and in 59 (33 in the placebo group (absolute difference 7% [95% CI ?3 to 17], number needed to treat 14; adjusted odds ratio 1?36 [95% CI 0?88?2?11]; p=0?16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.

Interpretation
Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2?8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.
0140-6736
557-568
Francis, Nick A.
9b610883-605c-4fee-871d-defaa86ccf8e
Cannings-John, Rebecca
f45c9562-b1d0-4c6d-9c7c-8f27cd3e47cd
Waldron, Cherry-Ann
74f893bb-7b67-4f67-b598-7d598cfd4085
Thomas-Jones, Emma
ea15d5ac-8232-4823-ab40-17bec0968520
Winfield, Tom
d042f1dd-304b-4c41-b01b-dfbce7655b2d
Shepherd, Victoria
b0622fcc-79c1-4a83-8457-ec5ae3911bb3
Harris, Debbie
60588324-3deb-4ea7-b1b0-4ff40db466db
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Fitzsimmons, Deborah
4e282651-162f-48f0-bbf7-190c265279f2
Roberts, Amanda
c4a5d206-49c3-4a07-8cfd-5bccf8c93b3b
Powell, Colin
528955fc-9d9d-4e07-9878-878b405f8e62
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434
Francis, Nick A.
9b610883-605c-4fee-871d-defaa86ccf8e
Cannings-John, Rebecca
f45c9562-b1d0-4c6d-9c7c-8f27cd3e47cd
Waldron, Cherry-Ann
74f893bb-7b67-4f67-b598-7d598cfd4085
Thomas-Jones, Emma
ea15d5ac-8232-4823-ab40-17bec0968520
Winfield, Tom
d042f1dd-304b-4c41-b01b-dfbce7655b2d
Shepherd, Victoria
b0622fcc-79c1-4a83-8457-ec5ae3911bb3
Harris, Debbie
60588324-3deb-4ea7-b1b0-4ff40db466db
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Fitzsimmons, Deborah
4e282651-162f-48f0-bbf7-190c265279f2
Roberts, Amanda
c4a5d206-49c3-4a07-8cfd-5bccf8c93b3b
Powell, Colin
528955fc-9d9d-4e07-9878-878b405f8e62
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434

Francis, Nick A., Cannings-John, Rebecca, Waldron, Cherry-Ann, Thomas-Jones, Emma, Winfield, Tom, Shepherd, Victoria, Harris, Debbie, Hood, Kerenza, Fitzsimmons, Deborah, Roberts, Amanda, Powell, Colin, Gal, Micaela and Butler, Christopher C. (2018) Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial. The Lancet, 392 (10147), 557-568. (doi:10.1016/S0140-6736(18)31490-9).

Record type: Article

Abstract

Background
Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.

Methods
In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2?8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.

Findings
Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40 children in the oral steroid group and in 59 (33 in the placebo group (absolute difference 7% [95% CI ?3 to 17], number needed to treat 14; adjusted odds ratio 1?36 [95% CI 0?88?2?11]; p=0?16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.

Interpretation
Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2?8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.

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More information

Accepted/In Press date: 1 January 2018
e-pub ahead of print date: 16 August 2018
Published date: 18 August 2018
Additional Information: This is an Open Access article under the CC BY-NC-ND 4.0 license.

Identifiers

Local EPrints ID: 436099
URI: http://eprints.soton.ac.uk/id/eprint/436099
ISSN: 0140-6736
PURE UUID: 2095a195-a140-4c52-a84f-a47c5dc08a63
ORCID for Nick A. Francis: ORCID iD orcid.org/0000-0001-8939-7312

Catalogue record

Date deposited: 27 Nov 2019 17:30
Last modified: 17 Mar 2024 03:58

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Contributors

Author: Nick A. Francis ORCID iD
Author: Rebecca Cannings-John
Author: Cherry-Ann Waldron
Author: Emma Thomas-Jones
Author: Tom Winfield
Author: Victoria Shepherd
Author: Debbie Harris
Author: Kerenza Hood
Author: Deborah Fitzsimmons
Author: Amanda Roberts
Author: Colin Powell
Author: Micaela Gal
Author: Christopher C. Butler

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